# K123013: Endoscopic Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Mar 22, 2013 after 175 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942044 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092221: Colonic Splinting Overtube, Model 00711145, United States Endoscopy Group, Inc. (2009) Summary page 1.
- K033954: Shape Locking Endoscopic Overtube, Usgi Medical, Inc. (2004) Summary page 1.
- K770291: Sigmoidoscope, Disposable, Model #53125, Welch Allyn, Inc. (1977) Summary page 1.

## Indications for use
The Novadaq Disposable Rigid Scope Introducer is intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon.

Source page: https://510kreport.com/device/K123013
Methodology: https://510kreport.com/methodology